Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 18, Issue 4, Pages 611-630Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543400802071303
Keywords
binary data; correlation structure; grid computing; mixture data; non-normality; non-compliance; ordinal data; patient dropouts; survival data
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A generic template for clinical trials simulations that are typically required by statisticians is developed. Realistic clinical trials data sets are created using a unifying model that allows general correlation structures for endpoint*timepoint data and nonnormal distributions (including time-to-event), and computationally efficient algorithms are presented. The model allows for patient dropout and noncompliance. A grid-enabled SAS-based system has been developed to implement this model; details are presented summarizing the system development. An example illustrating use of the system is given.
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